DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4, 6-11, 13, 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A, Prong 1: identify the abstract ideas.
Claims 1 and 11 recite the step of determining whether a sample is infected using a difference value from a signal from a first and second spectrum sensors at two time points. This is considered a mental process on a general computer of gathering and comparing values. Regarding the controller (claim 1)/processor (claim 11) performing the step of determining, MPEP 2106.04(a)(2)(III)(C) states that methods of performing a mental process on a generic computer, performing a mental process in a computer environment, or using a computer as a tool to perform a mental process are all claims that recite a mental process.
Dependent claims 3-4, 6-8 and 13, 15-17 recite different steps of the mental process, such as the equations or values in the equations of the abstract idea.
Dependent claims 9, and 10 do not recite the abstract idea, but recite a communication unit (claim 9), and an external terminal (claim 10).
Dependent claims 18, 19, and 20, recite "computer program" "a terminal" and "a diagnostic system" which does not appear to add additional limitations.
Step 2A, Prong 2: has the abstract idea been integrated into a particular practical application?
The collecting of the values is performed by a first spectrum sensor and a second spectrum sensor. These are considered merely indicating a field of use or technological environment in which to apply the judicial exception (see MPEP 2106.05(h): example vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). The two sensors are merely collecting the signals to analyze using the controller. These are considered data gathering and analyzing steps that are insignificant extra-solution activity in the field of sensing. The heater is considered a field of use for sensing so would not integrate the abstract idea into a particular practical application.
Dependent claims 3-4, 6-8 and 13, 15-17 appear to also fail as they recite limitations considered data gathering and analyzing steps that are insignificant extra-solution activity in the field of sensing.
Dependent claims 9, and 10 recite a communication unit (claim 9), and an external terminal (claim 19) are considered in the field of use for sensing so would not integrate the abstract idea into a particular practical application.
Dependent claims 18, 19, and 20, recite "computer program" "a terminal" and "a diagnostic system" which does not appear to add additional limitations.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea?
The claims recite the sensors and the controller to perform the abstract idea on the data gathering steps. The sensors and controller are considered to be routine and conventional. See Hayward, US2018016627, that teaches the sensor, controllers, data gathering, and heater.
Dependent claims 9, and 10 do not recite the abstract idea, but recite a communication unit (claim 9), and an external terminal (claim 19)
Dependent claims 18, 19, and 20, recite "computer program" "a terminal" and "a diagnostic system" which does not appear to add additional limitations and are considered to be routine and conventional.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 6-11, 13, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayward et al (US 2018016627).
Regarding claim 1, Hayward teach a test apparatus (Para. 0087-0088: portable device Axxin T8-ISO for isothermal DNA amplification) comprising:
a measurement unit configured to measure a change in a color of a solution contained in a test tube and a change in a color of a solution in a control tube, wherein, depending on a presence or absence of a nucleic acid in the solution in the test tube, as the nucleic acid in the test tube is amplified, the color change of the solution in the test tube occurs and, depending on a presence or absence of a nucleic acid in the solution in the control tube, as the nucleic acid in the control tube is amplified the change in color of the solution contained in the control tube occurs (Para. 0088:Axxin T8-ISO uses fluorescence detection that changes the color emission with amplification of nucleic acid in presence of the positive nucleic acid, no change in absence of the nucleic acid) ,wherein the measurement unit comprises:
a first spectrum sensor configured to output a signal related to a wavelength of light emitted from a first light source and transmitted through a control tube (Para. 0088:Axxin T8-ISO uses fluorescence detection in a reference, no DNA in unmarked control capsule) ;
a second spectrum sensor configured to output a signal related to a wavelength of light emitted from a second light source and transmitted through a test tube (Para. 0097-0088: Axxin T8-IS0 uses fluorescence detection in a sample capsule with DNA samples); and
a controller (Para. 0087: PC for data analysis) configured to determine whether a sample is infected using a difference value (hereinafter, referred to as a “test spectrum difference value”) between a value of a signal output from the second spectrum sensor at a preset first time point wherein the test spectrum difference value indicates the change in the color of the solution in the test tube (Fig. 2B change in fluorescence emission spectrum) and a value of a signal output from the second spectrum sensor at a preset second time point different from the first time point compared to a difference value (hereinafter, referred to as a “control spectrum difference value”) between a value of a signal output from the first spectrum sensor at the first time point and a value of a signal output from the first spectrum sensor at the second time point, wherein the control spectrum difference value indicates the change in the color of the solution in the control tube (Para. 0088, Fig. 2B: the output of the Axxin device in which the capsule with DNA tag is detected by the significant increase signal after 20 minutes compared to the absence of increase in the unmarked control capsule to indicate no DNA is detected), and a heating unit configured to heat the test tube and the control tube, as the nucleic acid in the test tube is amplified and as the nucleic acid in the control tube is amplified, according to a control signal output from the controller (Para. 0103: Axxin T8-IS0 uses a heater to maintain the temperature at 38C).
Hayward teach detecting the presence or absence of DNA by comparing the first and second spectrum sensors at least two time points (Para. 0087-0088; Fig. 2B: +DNA is zero at start and positive at end; -DNA is negative for DNA for start and end). Hayward further allows for machine to have learned a pattern (Para. 0024) and the use of algorithm to remove the need for human interpretation (Para. 0025). Hayward is silent to using the following equation: K = (T2 - T1) / (C2 - C1); K denotes an infection determination value, T2 denotes a value output from the second spectrum sensor at the second time point, T1 denotes a value output from the second spectrum sensor at the first time point, C2 denotes a value output from the first spectrum sensor at the second time point, and C1 denotes a value output from the first spectrum sensor at the first time point.
Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the equation above for the algorithm or the machine learned pattern of Hayward because the comparison equation is process that was being employed by comparing the spectrum levels at different times for the two sensors and to provide the above advantage of removing the need for human interpretation.
Regarding claim 3, Hayward teach an isothermal DNA amplification in one embodiment (Fig. 2B, Para. 0024, 0087-0088). Hayward isothermal embodiment is silent to the first time point is a time point adjacent to a time point at which the controller terminates heating operation of the heating unit; and the second time point is a time point when a preset time has elapsed since the controller terminated the heating operation of the heating unit. Hayward teaches in another embodiment using qPCR (Fig. 2C, para. 0025: denaturation (heating), annealing (cooling), extension (heating) then analyzing in real time after a predetermined time from the cooling (reads on "after the controller terminates heating operations"). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the qPCR embodiment having the second time point is a time point when a preset time has elapsed since the controller terminated the heating operation of the heating unit for the isothermal DNA amplification embodiment because they are known ways to amplify DNA and to provide the advantage of analyzing the extension of the DNA is real time.
Regarding claim 4, Hayward teach an isothermal DNA amplification in one embodiment (Fig. 2B, Para. 0024, 0087-0088). Hayward isothermal embodiment is silent to explicitly disclosing a temperature sensor configured to output a temperature value of the control tube, the test tube, or the heating unit, wherein the second time point is a time point when the temperature value output from the temperature sensor reaches a preset temperature value after the controller terminates heating operation of the heating unit.
Hayward teach using a Real time TaqMan qPCR using a MyGo mini device (Para. 0025: The device includes a temperature sensor configured to output a temperature value of the control tube, the test tube, or the heating unit, wherein the second time point is a time point when the temperature value output from the temperature sensor reaches a preset temperature value after the controller terminates heating operation of the heating unit.(Fig. 2B: qPCR includes denaturation (heating), annealing (cooling), extension (heating) then analyzing in real time after a predetermined time from the cooling (reads on "after the controller terminates heating operations"). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the qPCR using the MyGo mini device embodiment having the second time point is a time point when the temperature value output from the temperature sensor reaches a preset temperature value after the controller terminates heating operation of the heating unit for the isothermal DNA amplification embodiment because they are known ways to amplify DNA and to provide the advantage of analyzing the extension of the DNA is real time.
Regarding claims 6, 15, Hayward teach the infection determination value (K) is greater than or equal to a preset reference value, the controller determines that a result of determining whether the sample is infected is positive. (Para. 0024, Fig. 2B: positive when above the negative control)
Regarding claim 7, Hayward teach the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, the controller determines whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value. (Fig. 2B: +DNA greater than the -DNA level)
Regarding claim 8, 17, Hayward teach the value of the signal output from the first spectrum sensor at the second time point is greater than or equal to a preset measurement invalidity determination reference value and when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, the controller determines whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value. (Fig. 2B: +DNA value versus -DNA value)
Regarding claim 9, Hayward teach a communication unit configured to transmit the value of the signal output from the first spectrum sensor, the value of the signal output from the second spectrum sensor, or information on whether the sample is infected as determined by the controller. (Para. 0024: data exported to laptop or PC)
Regarding claim 10, Hayward teach a diagnostic system comprising: the test apparatus according to claim 1; and an external terminal configured to receive data transmitted from the test apparatus and display information on whether a sample is infected. (Para. 0024: data exported to laptop or PC and viewed)
Regarding claim 11, Hayward teach a test method comprising:
measuring with a measurement unit configured to measure a change in a color of a solution contained in a test tube and a change in a color of a solution in a control tube, wherein, depending on a presence or absence of a nucleic acid in the solution in the test tube, as the nucleic acid in the test tube is amplified, the color change of the solution in the test tube occurs and, depending on a presence or absence of a nucleic acid in the solution in the control tube, as the nucleic acid in the control tube is amplified the change in color of the solution contained in the control tube occurs (Para. 0088:Axxin T8-ISO uses fluorescence detection that changes the color emission with amplification of nucleic acid in presence of the positive nucleic acid, no change in absence of the nucleic acid) ,wherein the measurement unit comprises: a first spectrum sensor and a second spectrum sensor;
an operation (a) of calculating, by a processor, a difference value (hereinafter, referred to as a “control spectrum difference value”) between a value of a signal output from a first spectrum sensor that outputs a signal related to a wavelength of light emitted from a first light source and transmitted through a control tube at a preset first time point, and a value of a signal output from the first spectrum sensor at a preset second time point different from the first time point, wherein the control spectrum difference value indicates the change in the color of the solution in the control tube (Para. 0024, 0087-0088; Fig. 2B: color change as the detected fluorescence is a color emission from the sample with control is shown with -DNA);
an operation (b) of calculating, by the processor, a difference value (hereinafter, referred to as a “test spectrum difference value”) between a value of a signal output from a second spectrum sensor that outputs a signal related to a wavelength of light emitted from a second light source and transmitted through a test tube at the first time point, and a value of a signal output from the second spectrum sensor at the second time point (T2), wherein the test spectrum difference value indicates the change in the color of the solution in the test tube (Para. 0024: Fig. 2B: color change as the detected fluorescence is a color emission from the sample with control is shown with +DNA)) ; and
an operation (c) of determining, by the processor, whether a sample is infected using the test spectrum difference value compared to the control spectrum difference value. (Para. 0024: quantitative isothermal determining if the positive or negative for the DNA).
Hayward teach detecting the presence or absence of DNA by comparing the first and second spectrum sensors at least two time points (Para. 0087-0088; Fig. 2B: +DNA is zero at start and positive at end; -DNA is negative for DNA for start and end). Hayward further allows for machine to have learned a pattern (Para. 0024) and the use of algorithm to remove the need for human interpretation (Para. 0025). Hayward is silent to using the following equation: K = (T2 - T1) / (C2 - C1); K denotes an infection determination value, T2 denotes a value output from the second spectrum sensor at the second time point, T1 denotes a value output from the second spectrum sensor at the first time point, C2 denotes a value output from the first spectrum sensor at the second time point, and C1 denotes a value output from the first spectrum sensor at the first time point.
Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the equation above for the algorithm or the machine learned pattern of Hayward because the comparison equation is process that was being employed by comparing the spectrum levels at different times for the two sensors and to provide the above advantage of removing the need for human interpretation.
Regarding claim 13, Hayward teach the first time point and the second time point have an interval which is greater than or equal to a preset time. (Fig. 2B: start and finish are 15 minutes. It is noted that "a preset time" is sufficiently broad to read on any time, thus 15 minutes is an interval greater than a time such as 5 minutes)
Regarding claim 16, Hayward teach the operation (c) includes, when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, an operation of determining, by the processor, whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value. (Para. 0024, Fig. 2B: positive or negative result)
Regarding claim 18, Hayward teach a computer program written to perform each of the operations of the test method according to claim 11 on a computer and recorded on a computer-readable recording medium. (Para. 0024: machine display and PC summary, ranked according to the order the sample is loaded onto the machine. This allows the machine to learn a pattern and call a result as-is)
Regarding claim 19, Hayward teach a terminal comprising: a processor configured to perform each of the operations of the test method according to claim 11 (Para. 0024: machine display and PC summary); and a communication unit configured to receive, from a test apparatus, a value of a signal output from the first spectrum sensor and a value of a signal output from the second spectrum sensor (Para. 0024: Data exported to a PC).
Regarding claim 20, Hayward teach a diagnostic system comprising: the terminal according to claim 19 (Para. 0024: machine display and PC summary); and a test apparatus including the first spectrum sensor and the second spectrum sensor (Para. 0024: Axxin T8-ISO amplification block and detector).
Response to Arguments
Arguments regarding Rejection under 35 U.S.C. § 112(b) Claim 12 are convincing and therefore withdrawn.
Arguments regarding Rejection under 35 U.S.C. §101 Claims 1-20 are not convincing.
Regarding Step 2A Prong One: Applicants argue that the apparatus for and methodological steps of determining whether a sample is infected in instantly amended claims 1 and 11 are outside the realm of any mental process. Thus, the pending claims are not directed to a mental process. This is not convincing because the determining step comparing a test spectrum difference value and a control spectrum difference value is a mental process that can practically be performed by the human mind (see MEPEP 2106.04a2(III)B, the mathematical calculations that can be performed mentally with or without pen and paper are considered mental process). In this case, the mathematical calculations using the test spectrum and control spectrum are considered mental process and therefore an abstract idea.
Regarding Step 2A Prong Two: Applicant argues that the claim that "there is a need for a method of determining whether an infection is present even when an amount of a sample collected is small." and the heaters provide the integration into the practical application. This is not convincing because the size of the samples and the heaters are considered field of use for sensing so would not integrate the abstract idea into a particular practical application. Applicant also argues that the calculation of the value indicating whether an infection is present uses the particular functional relation of nucleic acid amplification and indicator color change, providing a clear improvement in the detection of viral or bacterial nucleic acids in a small sample size. This is not convincing because these improvements are considered in the field of use for sensing so would not integrate the abstract idea into a particular practical application.
Regarding Step 2B, Applicant argues that the amended independent claims 1 and 11 clearly recite subject matter that is significantly more in Step 2B because the claims clearly amount to significantly more because they provide concrete advantages in the field of molecular testing for disease. This is not convincing because the arguments are not within the scope of the claims. The argument focuses on "increased sensitivity and accuracy in the determination of whether a sample is infected, even when an amount of a sample collected is small" is not recited in the claim. The teaching of Hayward in the rejection supports the assertion that the sensors and controllers are routine and conventional.
Applicant's arguments filed 7/31/2025 have been fully considered but they are not persuasive.
Regarding the Rejection under 35 U.S.C. §102, applicant argues that Hayward fails to teach the amendments in independent claims 1 and 11. This is convincing as the claim has now been amendment to include claims 5 and 12. Regarding the other arguments regarding the color change. Applicant argues that "Hayward does not disclose the use of a color change that alters the spectral outputs of test and control samples undergoing nucleic acid amplification. Hayward also does not disclose an apparatus that can amplify nucleic acid in test and control tubes, heat the test and control tubes as the amplification occurs, and subsequently perform a series of steps, including a calculation, that allows a diagnostic system to determine whether, based on the spectral outputs, sufficient nucleic acid has been extracted from the sample (using preset invalidity and primary infection determination values for the control and test tubes, respectively) and whether the sample is infected." This is not convincing because the change in fluorescent marker amount that indicates the PCR has a positive or negative result (see Fig. 2B) is a color change as the detected fluorescence is a color emission from the sample. The change is the amount of fluorescence due the presence of DNA gives off an intensity within the color spectrum that correlates to the amplification of DNA and detection, thus reading on "color change".
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758